Anastomosis devices and methods

ABSTRACT

Methods and devices are provided for anastomosing tissue in the body. In one exemplary embodiment, an anastomotic device is provided having an elongate tubular body that is disposable through a body lumen and that includes proximal and distal portions. The proximal and distal portions can each include a plurality of asymmetrical s-shaped slits and can each be adapted to expand upon rotation to form proximal and distal wings. The proximal and distal wings can extend toward one another to engage tissue therebetween and thereby form a passageway through the tissue.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a divisional of U.S. patent application Ser.No. 11/876,131, filed on Oct. 22, 2007, now U.S. Pat. No. 9,301,761, andentitled “ANASTOMOSIS DEVICES AND METHODS,” which is hereby incorporatedby reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to methods and devices for forming ananastomosis between two body lumens.

BACKGROUND

Procedures to correct or relieve blocked or diseased luminal viscera ofthe body such as the bowel, bile duct, fallopian tube, ureter, and bloodvessels generally involve moving or bypassing the blocked or diseasedsegment and performing a surgical anastomosis. Typically, a portion of ablocked or restricted luminal viscous, or a lesion or tumor on theviscous wall, is removed, thereby forming a break in the lumen. Thebreak may then repaired by rejoining the two healthy luminal portionssuch as by suturing, stapling, or clamping the severed ends together.

Various apparatus have been suggested for anastomosing body lumens. Oneapparatus is a surgical anastomotic circular stapler. Generally, thesestaplers are inserted into and used to connect severed lumens with acircular ring of staples displayed around a circumference to connect thetissue. With this type of stapler, the tissue has to be intricatelyaligned along 360° of its cut surfaces before stapling so that no gapsexist between the connected tissue. Another apparatus is an anastomoticbutton made of metal or bioabsorbable material. These anastomoticdevices receive open ends of two tubular body organs to be anastomosedover a pair of ring members. The ring members have annular connectorswhich can mate with each other to clamp the tubular body organscontiguous to each other so that they can grow and heal together. Suchbuttons, however, can be bulky, awkward, and difficult to use andposition properly, particularly when used in tight quarters such asduring laparoscopic procedures.

Accordingly, improved methods and devices for forming an anastomosisbetween two body lumens are needed.

SUMMARY

The present invention generally provides methods and devices for joiningbody lumens. In one embodiment, an anastomotic device is provided havingan elongate tubular body that is disposable through a body lumen andthat includes proximal and distal portions. The elongate tubular bodycan be formed from various materials, but in an exemplary embodiment itis formed from at least one of a deformable and a resorbable material.The proximal and distal portions can each include a plurality ofasymmetrical s-shaped slits formed therein and adapted to expand uponrotation to form proximal and distal wings that can extend toward oneanother to engage tissue therebetween and thereby form a passagewaythrough the tissue. In an exemplary embodiment, a distance between theproximal and distal wings is adjustable during rotation of the elongatetubular body.

While the proximal and distal portions can have a variety ofconfigurations, in one embodiment, the proximal and distal portions eachinclude at least one tab adapted to couple with at least one elongatetubular body extending therethrough to secure the proximal and distalportions in a fixed position relative to the at least one elongatetubular body. In another embodiment, the proximal portion can be adaptedto be disposed in a first section of cut body lumen and the proximalwings can be adapted to engage the first section of body lumen. Thedistal portion can be adapted to be disposed in a second section of cutbody lumen and the distal wings can be adapted to engage the secondsection of body lumen. The proximal and distal wings can each have aplurality of tissue engaging mechanisms configured to grasp tissue asthe proximal and distal wings are formed.

The s-shaped slits can also have a variety of configurations. Forexample, the plurality of asymmetrical s-shaped slits formed in theproximal and distal portions can be adapted to bend at a location offsetfrom a mid-point of each slit. In still another embodiment, theplurality of asymmetrical s-shaped slits can extend longitudinally alongthe elongate tubular body in a proximal-distal direction and can bespaced axially around the elongate tubular body.

A system for joining tissue is also provided and in one embodiment, thesystem can include an inner elongate tubular body defining a fluid flowlumen therethrough. The system can also include an outer elongatetubular body disposed around the inner elongate tubular body. The outerelongate tubular body can include proximal and distal portions adaptedto expand upon rotation to fixedly engage the inner elongate tubularbody and to form proximal and distal wings that extend toward oneanother to engage tissue therebetween. In one embodiment, the outerelongate tubular body can include a plurality of slits formed in each ofthe proximal and distal portions and configured to allow the proximaland distal portions to expand to form proximal and distal wings. Theslits can extend, for example, longitudinally along the outer elongatetubular body in a proximal-distal direction, and they can be spacedaxially around the elongate tubular body. In another embodiment, theinner elongate tubular body can include at least one slot formedtherein. The outer elongate tubular body can include at least one tabformed thereon and adapted to engage the at least one slot to fixedlyanchor the outer elongate tubular body to the inner elongate tubularbody.

The system can also include an actuator removably coupled to the innerelongate tubular body and adapted to guide the inner elongate tubularbody and the outer elongate tubular body into a body lumen. In oneembodiment, the actuator includes an elongate shaft attached to thedistal portion of the outer elongate tubular body. In anotherembodiment, the actuator includes an outer shaft removably coupled tothe proximal portion of the outer elongate tubular body, and adapted toslide and rotate relative to the elongate shaft to expand the proximaland distal portions of the outer elongate tubular body.

A method for forming an anastomosis between two body lumens is alsoprovided, and in one embodiment the method can include positioning anelongate tubular body within at least one body lumen (e.g., theesophagus, the prostate, or a blood lumen). The proximal and distalportions of the elongate tubular body can be rotated, e.g., using anactuator, to cause the proximal and distal portions to expand to formproximal and distal wings that extend toward one another to engage atleast one body lumen therebetween and thereby form a fluid flow pathwaythrough the at least one body lumen. In one embodiment, the proximal anddistal wings can include tissue engaging mechanisms that grasp tissue asthe wings are formed. The wings can be formed by, for example,compressing the proximal and distal portions as they are rotated to formproximal and distal wings. The method can also include adjusting adistance between the proximal and distal wings. In other embodiments,the method can include anchoring the at least one body lumen to theelongate tubular body prior to rotating the proximal and distalportions. In one embodiment, positioning the elongate body can includeextending the elongate body between two openings in first and secondbody lumens to be joined.

In yet another embodiment, a method for occluding a body lumen isprovided and includes advancing an elongate tubular body into a bodylumen to be occluded, and rotating proximal and distal portions of theelongate tubular body to cause the proximal and distal portions toexpand to form proximal and distal wings that extend toward one anotherto engage the body lumen therebetween. The elongate tubular body canhave an inner lumen that is occluded such that fluid is prevented fromflowing through the elongate tubular body, thereby occluding the bodylumen.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a side view of one exemplary embodiment of an anastomoticdevice in an initial, unformed configuration;

FIG. 2 is a cross-sectional view of the anastomotic device of FIG. 1prior to deployment;

FIG. 3 is an end view of the anastomotic device of FIG. 1 followingdeployment;

FIG. 4 is a cross-sectional view of the anastomotic device of FIG. 1showing an inner tubular body;

FIG. 5 is a side view of the anastomotic device of FIG. 1 followingdeployment;

FIG. 6 is a cross-sectional view of central bend points of the wings ofthe anastomotic device of FIG. 5 following deployment;

FIG. 7 is a cross-sectional view of central bend points of wings ofanother embodiment of an anastomotic device following deployment;

FIG. 8 is a cross-sectional view of the anastomotic device of FIG. 5;

FIG. 9 is an enlarged view of a portion of the anastomotic device ofFIG. 8;

FIG. 10 is a perspective view of one exemplary embodiment of an actuatorfor deploying an anastomotic device, showing the anastomotic device ofFIG. 1 coupled thereto;

FIG. 11 is a side view of the anastomotic device of FIG. 1 and a distalportion of the actuator of FIG. 10;

FIG. 12 is a cross-sectional view of the anastomotic device and theinner shaft of FIG. 11;

FIG. 13 is a side view of one embodiment of a former tube for use withthe actuator of FIG. 10;

FIG. 14 is a side view of another embodiment of a former tube for usewith the actuator of FIG. 10;

FIG. 15 is a cross-sectional view of the handle portion of the actuatorof FIG. 10;

FIG. 16 is a perspective view of a proximal portion of the actuator ofFIG. 15 in an initial, starting position;

FIG. 17 is a perspective view of the proximal portion of the actuatorshown in FIG. 16 following deployment of the distal wings of ananastomotic device;

FIG. 18 is a perspective view of the proximal portion of the actuatorshown in FIG. 17 following deployment of the proximal wings of ananastomotic device;

FIG. 19 is a side view of the anastomotic device of FIG. 1 and an innershaft of the actuator of FIG. 10 being removed from the anastomoticdevice;

FIG. 20 is a side view of the anastomotic device of FIG. 19 and a distalgripper assembly of the actuator being removed from the anastomoticdevice;

FIG. 21 is a side view of the anastomotic device of FIG. 20 and theremainder of the actuator being removed from the anastomotic device;

FIG. 22 is a side view of the anastomotic device of FIG. 1 and a portionof the actuator of FIG. 10, showing the anastomotic device positionedrelative to two body lumens to be joined;

FIG. 23 is a cross-sectional view of the anastomotic device and theactuator of FIG. 22 following deployment of the distal wings;

FIG. 24 is a perspective view of an actuator following deployment of thedistal wings;

FIG. 25 is a perspective view of the actuator of FIG. 24 following fulldeployment of the proximal wings;

FIG. 26 is a cross-sectional view of the anastomotic device and theactuator of FIG. 23 following deployment of the proximal wings;

FIG. 27 is a cross-sectional view of the anastomotic device of FIG. 26following detachment of the actuator;

FIG. 28 is a cross-sectional view of the anastomotic device of FIG. 27and a supplemental elongate tubular body prior to its insertion into theanastomotic device;

FIG. 29 is a cross-sectional view of the anastomotic device of FIG. 27with the supplemental elongate tubular body of FIG. 28 disposed in theanastomotic device;

FIG. 30 is a side view of the anastomotic device of FIG. 1 and a portionof the actuator of FIG. 10, showing another embodiment of theanastomotic device positioned close to two body lumens to be joined;

FIG. 31 is a partially cross-sectional view of the anastomotic device ofFIG. 30 advanced into a body lumen and with the distal wings deployed;

FIG. 32 is a cross-sectional view of the anastomotic device of FIG. 31with the proximal wings deployed to engage the two body lumens;

FIG. 33 is a partially cross-sectional view of the anastomotic deviceand the actuator portion of FIG. 11 disposed through an esophagus andwithin a stomach;

FIG. 34 is a partially cross-sectional view of the anastomotic deviceand the actuator portion of FIG. 33 with the distal wings deployed;

FIG. 35 is a partially cross-sectional view of the anastomotic device ofFIG. 34 with the proximal wings deployed;

FIG. 36 is a partially cross-sectional view of the anastomotic device ofFIG. 35 with a supplemental elongate tubular body disposed therein;

FIG. 37 is a partially cross-sectional view of the anastomotic deviceand the actuator portion of FIG. 34 with an endoscope advanced through ahole in the stomach;

FIG. 38 is a partially cross-sectional view of the anastomotic deviceand the actuator portion of FIG. 37 with a band fixed around theesophagus;

FIG. 39 is a partially cross-sectional view of the anastomotic device ofFIG. 38 with the proximal wings deployed;

FIG. 40 is a perspective view of another exemplary embodiment of ananastomotic device in an initial, unformed configuration;

FIG. 41 is a cross-sectional view of the anastomotic device of FIG. 40deployed in the stomach hole of FIG. 39;

FIG. 42 is a partially cross-sectional view of the anastomotic device ofFIG. 1 with its distal and proximal wings deployed around a prostate;

FIG. 43 is another partially cross-sectional view of the anastomoticdevice of FIG. 1 with its distal and proximal wings deployed around aprostate;

FIG. 44 is a perspective view of still another exemplary embodiment ofan anastomotic device in an initial, unformed configuration;

FIG. 45 is a cross-sectional view of the anastomotic device of FIG. 44deployed in an artery; and

FIG. 46 is a partially cross-sectional view of the anastomotic device ofFIG. 45 with its distal and proximal wings deployed.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope is defined solely by the claims. The features illustrated ordescribed in connection with one exemplary embodiment may be combinedwith the features of other embodiments. Such modifications andvariations are intended to be included within the scope of the presentapplication.

The present invention provides methods and devices for joining bodylumens in tissue (living or synthetic). In general, the anastomoticdevice can be in the form of an elongate body that can be adapted to bedisposed through a body lumen (natural or artificial). The elongate bodycan include distal and proximal portions that are configured to radiallyexpand to engage tissue therebetween and thereby join body lumens. FIG.1 illustrates one exemplary embodiment of such an anastomotic device 10.The device 10 is illustrated in an initial, un-deployed configuration,and as shown the device 10 is in the form of a generally elongatetubular body 12 with an open proximal end 10 a and an open distal end 10b. The tubular body 12 can be formed from a variety of materialsincluding absorbable and non-absorbable materials. In an exemplaryembodiment, the device 10 is formed from a deformable material thatundergoes plastic deformation (i.e., deformation with negligible elasticcomponent). Exemplary materials include, by way of non-limiting example,any resorbable (e.g., biocompatible and/or bioabsorbable) materials,including, for example, titanium (and titanium alloys), magnesiumalloys, stainless steel, polymeric materials (synthetic and/or natural),shape memory material such as nitinol, ceramic, etc. Materials which arenot normally radiopaque, e.g., magnesium alloy, may be enhanced and madex-ray visible with the addition of x-ray visible materials, such asparticles of iron oxide, stainless steel, titanium, tantalum, platinumor any other suitable equivalents. The device 10 can also bemanufactured using various techniques. For example, the device 10 can beformed from a piece of tubing, or it can be formed from sheet stockmaterial. The developed surface of the final tubular shape may bestamped and folded into position. Various joining processes such aswelding, soldering, etc. may be used to join any seams.

As indicated above, the device 10 can include one or more portions thatexpand to engage tissue therebetween and thereby anastomose body lumens.In the embodiment shown in FIG. 1, the device 10 includes proximal anddistal portions 12 a, 12 b that are configured to expand to engagetissue therebetween. While various techniques can be used to allow theproximal and distal portions 12 a, 12 b to expand, in an exemplaryembodiment the proximal and distal portions 12 a, 12 b each include aplurality of slits 14 a, 14 b formed therein and configured to allowportions of the elongate tubular body 12 between the plurality of slits14 a, 14 b to radially expand, as will be discussed below. A mid-portion13 of the tubular body 12, located between the proximal and distalportions 12 a, 12 b, can be configured to be positioned between two cutbody lumens, e.g., within an anastomosis, so it can have a fixed oradjustable length that corresponds to a thickness of the tissue walls.The mid-portion 13 can have openings in the form of holes and/or slotsto allow it to expand/retract (e.g., with compression and/or torsion)and have variable length and/or diameter, or the mid-portion 13 can befree from any cut-outs and be non-expanding/non-retracting with a fixedlength and diameter.

The slits 14 a, 14 b in the proximal and distal portions 12 a, 12 b canextend in any direction, and each portion 12 a, 12 b can include anynumber of slits. Preferably, the slits 14 a, 14 b are configured suchthat certain portions of the elongate tubular body 12 between the slits14 a, 14 b will extend outward away from a central axis A of the tubularbody 12 when the body 12 is axially compressed, and preferably rotatedas well. As a result, one or more wings will form in each of the distaland proximal portions 12 a, 12 b to engage tissue therebetween. Thedevice 10 can also include tabs 15 a, 15 b in the distal and proximalportions 12 a, 12 b to aid in forming the wings, as discussed furtherbelow. In an exemplary embodiment, as shown in FIG. 1, the slits 14 a,14 b are curved in S-shapes that extend transverse to a central axis Aof the elongate tubular body 12 such that they at least partially extendaround the elongate tubular body 12. The slits 14 a, 14 b can extendlongitudinally along the elongate tubular body 12 in a proximal-distaldirection, and they can be spaced axially around the elongate tubularbody 12. More preferably, the slits 14 a in the distal portion 12 aextend in a first direction around a circumference of the elongatetubular body 12 and the slits 14 b in the proximal portion 12 b extendin a second, opposite direction around the circumference of the elongatetubular body 12. Such a configuration allows the tubular body 12 to berotated in a first direction to cause only one of the proximal anddistal portions 12 a, 12 b to radially expand, and then to be rotated ina second direction to cause the other one of the proximal and distalportions 12 a, 12 b to radially expand. Furthermore, the slits 14 a, 14b in an exemplary embodiment are asymmetrical such that the upper orlower curve of a slit's S-shape is greater in length than its oppositeside. This allows the slits 14 a, 14 b to bend at a location offset froma mid-point of each slit, thereby providing for generally uniformformation of the wings. A person skilled in the art will appreciate thatthe slits 14 a, 14 b can have a variety of other shapes and sizes, andthat they can extend in various directions, such as helical or parallelto the central axis A of the tubular body. The number and configurationof the slits 14 a, 14 b can be chosen so that a certain number of wingscan form at particular areas around the circumference of the device 10.The slits 14 a, 14 b can also include additional curved slits extendingfrom each end of the main slits 14 a, 14 b to ensure that the endprofile of the wings is aligned close to the elongate body 12 of theanastomotic device 10 following deployment. This can help ensure a fluidtight seal. The slits 14 a, 14 b can also have a thickness that narrowsthe width of the tubing section between slits thus encouraging the wingsto bend outward at this point.

FIGS. 2 and 3 show distal end views of the device 10 in its pre-deployedconfiguration and following partial or full deployment, respectively. Inthe pre-deployed configuration shown in FIG. 2, the elongate tubularbody 12 has a diameter that is configured to fit within a body lumen intissue and that may also be configured to fit within an introducersheath for guiding the device 10 to an anastomotic site, as will bediscussed in more detail below. FIG. 3 illustrates the distal portion 12b radially expanded to form the distal wings. When the proximal portion12 a is radially expanded to form the proximal wings, the proximal wingscan be aligned with the distal wings to facilitate lumen joining. Insuch a case, the distal end view of the device 10 would look as shown inFIG. 3 both before and after deployment of the proximal wings. Theproximal wings can also be offset radially from the distal wings. In theillustrated embodiment, the slits 14 a, 14 b are configured such thatthe proximal and distal portions 12 a, 12 b each include three wings,however the proximal and distal portions can include any number ofwings.

Referring again to FIG. 1, the proximal portion 12 a, the distal portion12 b, and/or the mid-portion 13 of the anastomotic device 10 canoptionally include tissue engaging mechanisms 17 formed or attachedthereon which can be configured to grasp (e.g., grip, hold, penetrate,and/or puncture) tissue engaged by the device 10. The device 10 caninclude any number tissue engaging mechanisms 17, and the tissueengaging mechanisms 17 can have any configuration on the device 10. Forexample, as shown in FIG. 1, the tissue engaging mechanisms 17 can be inthe form of protrusions, e.g., raised bumps and/or a textured surface,on some or all of an exterior surface of the elongate tubular body 12that can grip tissue. In another example, the protrusions 17 can be inthe form of gripping hooks attached to the elongate body 12 that canpenetrate and/or puncture tissue. Preferably, the protrusions 17 areformed on the proximal and distal portions 12 a, 12 b of the elongatetubular body 12 such that the protrusions 17 are on the wings whendeployed. The protrusions 17 can be configured on the elongate tubularbody 12 to only engage tissue when rotated in one direction. Theprotrusions 17 can facilitate anchoring of the anastomotic device 10 atan anastomotic site, and they can also be used to facilitate sealing ofan anastomotic site. During deployment of the device 10, the protrusions17 can grip tissue around the anastomotic device 10, and upon rotationof the wings can twist tissue in a spiral motion, thereby causing tissueto compress around the outer elongate tube 12 and seal the site. One ormore sutures (e.g., purse string sutures) can help secure the elongatetubular body 12 to tissue such that when a suture is pulled tight aroundthe tissue, tissue can be compressed into a protrusion 17 (e.g., a slot)or be prevented from moving by a protrusion 17 (e.g., a dimple). Theprotrusions 17 can also be configured so as to only engage tissue whenrotated in one direction.

As illustrated in FIG. 4, the elongate body 12 can also include one ormore tabs 11 a, 11 b in the distal and proximal portions 12 a, 12 b toaid in forming the wings. Any number of the tabs 11 a, 11 b can beformed on an inner surface of the elongate tubular body 12 around anyportion of its circumference. The number of tabs 11 a, 11 b can be thesame or can vary between the proximal and distal portions 12 a, 12 b.The tabs 11 a, 11 b can generally point in a downward direction (i.e.,away from one another), and they can couple with an inner, generallyelongate tubular body 18 extending through the elongate tubular body 12(also referred to as the outer elongate body 12) to secure the proximaland distal portions 12 a, 12 b in a fixed position relative to the innerelongate tubular body 18. The inner elongate body 18 can include atleast one slot 23 a, 23 b formed in its proximal and distal portions 25a, 25 b to mate with the tabs 11 a, 11 b, as discussed further below.

The inner elongate body 18 and the outer elongate body 12 are both shownin cross-sectional, undeployed configurations in FIG. 4. The innerelongate body 18 can be disposed in the outer elongate body 12 and canoptionally be attached to the inner elongate body 18, e.g., at themid-portion 13 of the outer elongate body 12 and at a mid-portion 27 ofthe inner elongate body 18 using a temporary or permanent connectingelement such as a biocompatible adhesive 19. Similar to the outerelongate body 12, the inner elongate body 18 has an open distal end 21 band an open proximal end 21 a. The inner elongate body 18 between theopen distal end 21 b and the open proximal end 21 a defines a fluid flowlumen therethrough extending along the central axis A.

The tabs 11 a, 11 b in the proximal and distal portions 12 a, 12 b ofthe outer elongate body 12 are adapted to engage the slots 23 a, 23 b inthe proximal and distal portions 25 a, 25 b of the inner elongate body18. The slots 23 a, 23 b can be cut through a wall of the inner elongatebody 18 and can have any size, shape, and configuration. In thisembodiment, the slots 23 a, 23 b are substantially rectangular and arearranged in substantially straight lines around the circumference of theinner elongate body 18. When one or more of the tabs 11 a, 11 b areengaged with one or more of the slots 23 a, 23 b, the outer elongatebody 12 is fixedly anchored to the inner elongate body 18. As such, theposition of the wings can be adjusted and fixedly held as explainedfurther below. One tab typically engages one slot, although each of theslots 23 a, 23 b can be configured to engage more than one of the tabs11 a, 11 b, e.g., by adjusting the width of the tabs 11 a, 11 b and/orthe slots 23 a, 23 b so that multiple tabs 11 a, 11 b can fit in one ofthe slots 23 a, 23 b.

FIG. 5 shows the anastomotic device 10 in a deployed configuration. Theinner elongate body 18 may or may not be disposed within the device 10and, if present, may or may not be visible at one or both of theproximal and distal ends 10 a, 10 b (it is present but not visible inFIG. 5). In the deployed configuration, the proximal portion 12 a isexpanded to form proximal wings 16 a, and the distal portion 12 b isexpanded to form distal wings 16 b. The wings 16 a, 16 b are formed bythe material between the slits 14 a, 14 b, which is deformed outward asthe outer elongate body 12 is compressed and preferably rotated. Thewings 16 a, 16 b can be concurrently or sequentially formed, e.g.,deploying the distal wings 16 b before the proximal wings 16 a.

The size and shape of the wings 16 a, 16 b can vary depending on thelocation and length of the slits 14 a, 14 b. In an exemplary embodiment,the size and shape of the wings 16 a, 16 b can be maximized to maximizethe contact area between the wings 16 a, 16 b and the tissue surroundingthe anastomotic site within which the device 10 is deployed. In thisembodiment, the wings 16 a, 16 b are substantially ovular-shaped andhave a generally planar relationship with each other such that the wings16 a, 16 b extend substantially parallel to one another, i.e., they areformed in parallel planes. In another configuration, the wings 16 a, 16b can converge or diverge with respect to one another. The proximalwings 16 a can be circumferentially offset, e.g., offset rotationally,relative to the distal wings 16 b to further maximize the contact areaaround the anastomotic ring. The proximal and distal wings 16 a, 16 bare also preferably configured to be positioned a distance apart fromone another. The length of the mid-portion 13 determines of the distancebetween a base portion of the wings 16 a, 16 b whilecompression/rotation of the device 10 determines the distance between atip portion of the wings 16 a, 16 b. Furthermore, a cut profile on oneside of a perpendicular axis B of the elongate tubular body 12 cangenerally be a mirror image of the opposite side. When the wings 16 a,16 b are deployed, the central bend points may be positioned directlyopposite the bend points for the other side as illustrated in FIG. 6.Alternatively, the slits 14 a, 14 b on each side may be offset so thatonce deployed the central bend points are also offset from each other asshown in FIG. 7. As the ends of the elongate tubular body 12 arerotated, these central sections generally close toward each other.

FIG. 8 shows a cross-sectional view of the deployed device 10 of FIG. 5.The asymmetric profile of the slits 14 a, 14 b can allow the wings 16 a,16 b to form such that interior base bend angles a1, a2 are less thanrespective exterior base bend angles β1, β2. As a result, the wings 16a, 16 b will also extend toward one another. The interior base bendangles α1, α2 can be the same or different in the proximal and distalportions 12 a, 12 b, as can the exterior base bend angles β1, β2. If theexterior base bend angles β1, β2 are each about 90 degrees, the wings 16a, 16 b extend substantially parallel to each other, while acute andobtuse exterior base bend angles β1,β2 can allow the wings 16 a, 16 b tobe angled toward each other at one end and away from each other at theopposite end. In FIG. 8, the inner elongate body 18 is disposed in theouter elongate body 12, and the proximal and distal tabs 11 a, 11 b areengaged with proximal and distal slots 23 a, 23 b. A cutaway section 31of the proximal portion 12 a in FIG. 9 shows one of the proximal tabs 11a engaged with one of the proximal slots 23 a, thereby fixedly anchoringthe outer elongate body 12 to the inner elongate tubular body 18.

A distance between the wings 16 a, 16 b can be controlled in a varietyof ways during rotation of the outer elongate body 12. The distancebetween the wings 16 a, 16 b can be constant, or the distance can vary.For example, the distance can be controlled by rotating and compressingthe outer elongate body 12 to varying degrees, thereby varying thedistance between the wings 16 a, 16 b. In another embodiment, thedistance can be controlled by expanding or contracting the mid-portion13. The distance could also be controlled by forming the wings 16 a, 16b and anchoring the tabs 11 a, 11 b in different rows of slots 23 a, 23b, thereby holding the wings 16 a, 16 b in a substantially fixedposition. FIG. 4 shows multiple rows of the slots 23 a for receiving thetabs 11 a at different longitudinal positions. Referring to FIG. 8, adistance D1 between the proximal and distal wings 16 a, 16 b can besubstantially the same as a distance D2 between the proximal and distalwings 16 a, 16 b at another location along the circumference of theouter elongate body 12. Alternatively, the distance D1 can be greaterthan D2 or less than D2 by disengaging the tabs 11 a, 11 b at either orboth the proximal and distal portions 12 a, 12 b and reengaging one ormore of the tabs 11 a, 11 b with another one or more of the slots 23 aas appropriate to increase or decrease the distance.

As indicated above, the wings 16 a, 16 b on the anastomotic device 10can be formed by compressing and preferably rotating the device 10.While various techniques can be used to deploy and actuate the device10, in one exemplary embodiment the anastomotic device 10 is removablycoupled to an actuator that can be adapted to guide the device 10 into abody lumen and to apply an axial and rotational force to the elongatetubular body 12 to cause the elongate tubular body 12 to extendoutwardly. FIGS. 10-12 and 15-21 illustrate one exemplary embodiment ofan actuator 20 for deploying the anastomotic device 10. In general, theactuator 20 includes a proximal portion in the form of a handle 22, andan elongate shaft extending distally from the handle 22. A distal end ofthe actuator 20 includes a digital gripper assembly 28 that is adaptedto removably couple to the anastomotic device 10. The elongate shaftincludes an outer shaft or former 24 that is disposed around and coupledto an assembly shaft 25, which itself is disposed around an inner shaft26. The inner shaft 26 is effective to hold a portion of the device 10in a fixed position by expanding the assembly shaft 25 (and possiblyalso the former 24) to allow the digital gripper assembly 28, which isformed on the distal end of the assembly shaft 25, to engage the device10, as described further below. With both the inner and assembly shafts26, 25 disposed within the former 24, the former 24 can be effective toapply axial and/or rotational forces to the anastomotic device 10 todeploy the anastomotic device 10.

The former 24 can have a variety of configurations, but it is preferablyadapted to detachedly couple to the proximal end 10 a of the anastomoticdevice 10. While various techniques can be used to couple the former 24to the anastomotic device 10, FIGS. 11 and 12 illustrate one exemplarytechnique. As shown, the former 24 includes one or more protrusions 24 athat can extend into one or more notches formed between tabs 15 a formedin the proximal end 10 a of the device 10 such that the protrusions 24 aand tabs 15 a interlock. Similarly, the digital gripper assembly 28 canalso have a variety of configurations, but it is shown as an expandabletubular member having one or more protrusions 28 b that can extendproximally into one or more notches formed between tabs 15 b formed inthe distal end 10 b of the device 10 such that the protrusions 28 b andtabs 15 b interlock. The distal gripper assembly 28 can be attached toor formed on the distal end of the assembly shaft 25, which is slidablydisposed through the former 24. For example, the distal gripper assembly28 can be attached to the anastomotic device 10 using a threadedattachment. Furthermore, the distal gripper assembly 28 can include oneor more thinned or weakened regions to help it collapse for itsdetachment and removal from the outer elongate body 12 as describedfurther below. The thinned or weakened region(s) can be achieved byreducing the amount of material at that region, or by scoring orotherwise removing some of the material used to form the distal gripperassembly 28.

The former 24 and/or the assembly shaft 25 can also be configured toprovide maximum flexibility during clinical use, while the inner shaft26 can be rigidly configured to provide structural support to the former24 and/or the assembly shaft 25. For example, the former 24 and/or theassembly shaft 25 can be formed from a flexible material, or the former24 and/or the assembly shaft 25 can include one or more flexible regionsformed thereon. FIGS. 13 and 14 show exemplary embodiments of flexibleregions. In the embodiment shown in FIG. 13, the tube includes aninterrupted slotted pattern 30. In the embodiment shown in FIG. 14, thetube includes a spiral slit or interrupted spiral slit 32 cut throughthe wall of the tube. Such configurations provide flexibility along allor portions of the former 24 and/or the assembly shaft 25, but can alsoensure that an axial and/or rotational force applied to one end of theformer 24 will be transmitted along the length of the former 24 and/orthe assembly shaft 25 to the other end.

In order to rotate the former 24 relative to the assembly shaft 25 andthe inner shaft 26 and thereby form the wings 16 a, 16 b, the handle 22of the actuator 20 can optionally include an actuation mechanism formedthereon. In an exemplary embodiment shown in FIGS. 15-18, the handle 22includes an outer collar 36 rotatably disposed therearound and havingguide tracks 38 formed therein. The outer collar 36 can be coupled to aproximal portion of the former 24 such that rotation of the collar 36 iseffective to rotate the former 24. The proximal end of the assemblyshaft 25 can also include an inner collar 37 that is attached to theassembly shaft 25 and that includes a pin 40 formed thereon or extendingtherefrom. The pin 40 extends through and is positioned within the guidetracks 38. Since the position of the pin 40 is fixed due to the assemblyshaft 25 being fixed, movement of the outer collar 36, and thus theformer 24, is governed by the configuration of the guide tracks 38 whichcan move relative to the fixed pin 40. As a result, the guide tracks 38can be used to control the axial and rotational forces applied to theanastomotic device 10 coupled to the distal end of the former 24.

As shown in FIGS. 16-18, the guide tracks 38 can have a configurationthat allows the collar 36 to rotate in a first direction, e.g., counterclockwise, to deploy the distal wings 16 b of the anastomotic device.The distal wings 16 a, 16 b can be deployed before or after the proximalwings 16 a although they are deployed first in this example. Inparticular, as the outer collar 36 is rotated counter clockwise, theformer tube 24 will rotate in a counter-clockwise direction, therebyrotating the proximal end 10 a of the anastomotic device 10 to expandthe distal wings 16 b of the anastomotic device 10. The gripper 28 willremain in a fixed position, thus holding the distal end 10 b of thedevice 10 in a fixed position while the proximal end 10 a is rotated. Aspreviously discussed, since the slits 14 a, 14 b in the distal andproximal portions 12 a, 12 b preferably extend in opposite directions,rotation of the anastomotic device 10 in a first direction will onlydeploy the distal wings 16 b. Once the outer collar 36 is fully rotated,the guide tracks 38 can allow distal movement of the outer collar 36,while the guide pin 40 remains in a fixed position at all times, thusallowing the outer collar 36 to be advanced distally. As a result, theformer tube 24 will apply compressive forces on the anastomosis device10, thereby causing the distal wings 16 b to collapse into asubstantially planar configuration.

The guide tracks 38 can then allow the outer collar 36 to rotate in anopposite direction, e.g., a clockwise direction, to cause the formertube 24 to rotate clockwise. As the former 24 rotates clockwise, theproximal wings 16 a will expand. Once the outer collar 36 is fullyrotated, the guide tracks 38 can allow distal movement of the outercollar 36 therein, thus allowing the outer collar 36 to be advanceddistally. As a result, the former tube 24 will apply compressive forceson the anastomotic device 10, thereby causing the proximal wings 16 a tocollapse into a substantially planar configuration in which they extendtransverse to the axis A (see FIGS. 1 and 4) of the device 10.

A person skilled in the art will appreciate that the guide tracks 38 canhave a variety of other configurations. For example, rather thanallowing rotation, and then distal movement, the guide tracks 38 canextend at an angle around the handle 22 to allow rotational andcompressive forces to be simultaneously applied to the anastomoticdevice 10. A person skilled in the art will appreciate that a variety ofother techniques can be used to actuate the former 24 to deploy thedevice.

Once the device 10 is deployed, the actuator 20 can be removed. Forexample, the distal gripper assembly 28 can be configured such that itcan disengage from the outer elongate body 12 when a force is appliedthereto. In use, the distal gripper assembly 28 can be collapsed byremoving the inner shaft 26, which allows the distal gripper assembly 28to return to an unexpanded state in which it can be retracted throughthe device 10. During use, the distal gripper assembly 28 can be rotatedrelative to the anastomotic device 10 so as to unscrew the distalgripper assembly 28 from the anastomotic device 10. Once detached, thedistal gripper assembly 28 (and the former 24) can be removed from thepatient, leaving the anastomotic device 10 in position at theanastomotic site. A person skilled in the art will appreciate that avariety of mating techniques can be used, including, for example, aninterference fit, a mechanical interlock, etc.

FIGS. 19-21 illustrate a distal portion of the outer shaft 24, theassembly shaft 25, and the inner shaft 26 of the actuator 20 in use withthe anastomotic device 10. Following deployment of the anastomoticdevice 10, the actuator 20 is preferably disconnected and removed fromthe patient. In FIG. 19, the protrusions 24 a on the former 24 areremoved from the corresponding cut-outs formed between the tabs 15 a inthe proximal end 10 a of the device 10. The inner shaft 26 can then bewithdrawn from the assembly shaft 25 and the outer shaft 24 in a distaldirection. Removing the inner shaft 26 can cause the distal end of theassembly shaft 25 to collapse inwards as shown by the directional arrowsin FIG. 20. The diameter of the assembly shaft 25 can thereby be reducedso that it and the attached or coupled distal gripper assembly 28 can bemoved through the inner elongate body 18. The entire remaining actuatorassembly (e.g., the assembly and outer shafts 25, 24) can be withdrawnin a distal direction as shown in FIG. 21, thereby leaving the device 10deployed and engaging tissue. The device 10 can also be removed from thebody after deployment, if necessary. For example, the tabs 11 a, 11 b(if in use) can be disengaged from the slots 23 a, 23 b, the wings 16 a,16 b can be collapsed to their original, flat, undeployed configuration,the protrusions 17 (and any sutures) can be disengaged from tissue ifnecessary, and the device 10 can be removed from the body.

The present invention also provides exemplary methods for joining bodylumens in tissue. While various devices can be used to effect the methodin one embodiment, the device 10 can be delivered to a lumen over aguidewire. The proximal end of the guidewire, which extends from thepatient, can be inserted into an opening at the distal end 10 b of theanastomotic device 10 or through the inner shaft 26 if it is hollow. Theguidewire can extend through the shaft and handle 22 of the actuator 20,or in other embodiments it can exit through a side hole located eitherin the anastomotic device 10 or at the distal end of the former 24.

FIG. 22 illustrates the distal end of the actuator 20, coupled with thedevice 10, disposed in a proximal cut lumen 54 a to be joined with adistal cut lumen 54 b. Typically, the proximal and distal cut lumens 54a, 54 b were previously part of a single, continuous lumen, but adiseased or otherwise unwanted portion of the lumen was cut away,leaving the two cut lumens 54 a, 54 b to be rejoined into a singlelumen. The actuator 20 and the device 10, still disposed through in theproximal cut lumen 54 a, can be advanced through the distal cut lumen 54b such that the device 10 is disposed at least partially in each of thecut lumens 54 a, 54 b. Preferably, the proximal portion 12 a of theouter elongate tube 12 is substantially positioned in the proximal cutlumen 54 a and the distal portion 12 b of the outer elongate tube 12 issubstantially positioned in the proximal cut lumen 54 b. Ends 56 a, 56 bof the cut lumens 54 a, 54 b can be positioned to abut each other suchthat the mid-portion 13 of the outer elongate body 12 is substantiallybetween the cut lumens 54 a, 54 b, either before either of the wings 16a, 16 b are deployed or, preferably, after the distal wing 16 b isdeployed but before the proximal wing 16 a is deployed. A suture canoptionally be used to secure one or both cut lumens 54 a, 54 b to theouter elongate body 12. With the device 10 disposed in both of the cutlumens 54 a, 54 b, the wings 16 a, 16 b can be deployed and the cutlumens 54 a, 54 b can be joined. In this example the ends 56 a, 56 b areopen, but if the ends 56 a, 56 b are closed (e.g., by staples, suture,etc.), a pointed tip 20 b at a distal end of the inner shaft 26, orother cutting element, can be used to puncture the ends 56 a, 56 b wheninserting the actuator 20 and the device 10 into the lumens 54 a, 56 b.

FIG. 23 illustrates the actuator 20 disposed in the cut lumens 54 a, 54b with the distal wing 16 b deployed. Once the anastomotic device 10 ispositioned to be deployed, the outer collar 36 on the handle 22 of theactuator 20 can be rotated in a first direction, e.g., counter-clockwiseas shown in FIG. 24, to cause the distal portion of the anastomoticdevice 10 to expand away from the central axis. A compressive force cansimultaneously or subsequently be applied to the anastomotic device 10to cause the expanded portions of the anastomotic device 10 to collapse,and thereby form distal wings 16 b, as shown in FIG. 23. Suture and/orthe protrusions 17 of the distal end 10 b of the device 10 can be usedto help grip the distal cut lumen 54 b to help guide it into a wingedconfiguration that substantially mirrors the configuration of the distalwing 16 b.

Following deployment of one of the distal and proximal wings 16 a, 16 b,the other one of the wings 16 a, 16 b can be similarly deployed toanastomosis the lumens 54 a, 54 b. The proximal wings 16 a can bedeployed by rotating the actuator outer collar 36 in an oppositedirection, e.g., a clockwise direction, as shown in FIG. 25. This inturn can cause the former 24 to rotate the proximal end of theanastomotic device 10 in a clockwise direction causing the proximalportion 12 a of the anastomotic device 10 to expand outward. The former24 can be simultaneously or subsequently advanced distally causing theexpanded portions of the anastomotic device 10 to collapse and form theproximal wings 16 a, as shown in FIG. 26. Thus, the distal and proximalwings 16 a, 16 b can extend toward one another and engage the tissue ofthe cut lumens 54 a, 54 b therebetween and thereby form a fluid flowpathway between the lumens 54 a, 54 b. As illustrated in FIG. 27, withthe device 10 deployed and the anastomosis site sealed, the actuator 20can be removed from the device 10 as previously discussed.

In some instances the lumen diameter at the anastomotic junction maydesirably be reduced. One way this can be achieved is shown in FIG. 28by inserting into the device 10 a supplemental elongate tubular body 58having an open diameter smaller than the open diameter of the innerelongate body 18. The supplemental elongate body 58 can be formed from avariety of materials, including absorbable and non-absorbable materials,such as those described above. The supplemental elongate body 58 can beinserted through the proximal end 10 a of the device 10 as shown, or itcan be inserted through the distal end 10 b. The supplemental elongatebody 58 can be locked into position using any technique, such as with alatch or bayonet type of fixing to the device 10 (e.g., at an insidewall of the inner elongate body 18) or by increasing its diameter. Oncein position as shown in FIG. 29, the lumen diameter is reduced from itspre joining configuration at the point of the anastomotic junction. Thesupplemental elongate body 58 can be removed in a variety of ways,similar to how the device 10 can be removed, such as by inserting a rod,attaching its distal end to the supplemental elongate body 58, detachingthe supplemental elongate body 58 from the inner elongate body 18, andremoving the supplemental elongate body 58 from the body.

In yet another embodiment, the device can be used for total occlusion ofa body lumen, such as the fallopian tube. For example, the device ofFIGS. 28 and 29 can include a solid member adapted to be disposedtherein to prevent fluid from passing therethrough. In particular, thesupplemental elongate body 58 can be a substantially solid tubularmember that is disposed within the device 10. Alternatively, the device10 can have a solid inner member that prevents passage of fluidtherethrough. In use, the device can be advanced into a lumen to beoccluded, such as the fallopian tube. One set of wings can be deployed,and protrusions, if present, can engage the wall of the lumen. Thesecond set of wings can also be deployed thereby compressing andcapturing the wall of the lumen between both sets of deployed wings, andalso anchoring the occluder device in position. As indicated above, thecentral portion of the device can be solid to prevent passage of fluidfrom one side to the other side.

In some embodiments, the device 10 can be used to create an end-to-sideanastomotic junction as shown in FIGS. 30-32. The device 10 disposedaround the actuator 20 can be advanced through a first section of bodylumen 42 as described above. The pointed tip 20 b of the inner shaft 26,or other cutting element, can optionally be used to puncture a wall of asecond section of body lumen 44. Then as shown in FIG. 31, the device 10can be advanced into the second section of body lumen 44 and the distalwings 16 b can be deployed as described above. The first section of bodylumen 42 can then be advanced to abut the second lumen 44 against itssidewall. The proximal wings 16 a can then be deployed, thereby creatinga compressed seal between the end section of the first lumen 42 and thewall of the second lumen 44 as shown in FIG. 32. Suture can be used tosecure the sections of body lumen 42, 44 in position, e.g., at themid-portion 13 of the outer elongate body 12.

The device 10 can also be used to create a side-to-side anastomoticjunction similar to the end-to-side anastomotic junction describedabove. To form a side-to-side junction, the device 10 can be advancedthrough a first section of body lumen and the pointed tip 20 b of theinner shaft 26, or other cutting element, can be used to puncturethrough its side wall and then through a side wall of a second sectionof body lumen. Distal wings can then be deployed within the firstsection of body lumen and proximal wings deployed within the secondsection of body lumen to create the side-to-side junction.

The anastomotic device 10 can also be used to restrict the size of anopening between two body tissues such as an esophagus 60 and a stomach62 as shown in FIGS. 33-35. A flexible endoscope 64 can be advancedthrough the esophagus 60 and into the stomach 62. The actuator 20 inthis embodiment is ideally hollow to accommodate the endoscope 64, whichis typically advanced into the patient before the actuator 20 and theanastomotic device 10. The device 10, coupled to the actuator 20, can beadvanced over the endoscope 64, down through the esophageal junction andinto the stomach 62. The distal end of the scope 64 can be positioned sothat its lens 66 can look back at the anastomotic ring assembly asillustrated in FIG. 34. In this way, medical personnel can have aninternal view of the stomach 62 and/or the esophagus 60 to moreaccurately position the device 10 inside the body and deploy the distalwings 16 b in the appropriate position. Once the distal wings 16 b aredeployed, the device 10 can be pulled back toward the esophagus 60 alongthe scope 64 until the deployed distal wings 16 b make contact with awall 68 of the stomach 62. The proximal wings 16 a can then be deployed,thereby pushing tissue toward the mid-portion 13 of the anastomoticdevice 10 while compressing tissue between both sets of deployed wings16 a, 16 b. Thus, a junction of fixed diameter can be formed between theesophagus 60 and the stomach 62 as shown in FIG. 35. With the tissuejoined, the actuator 20 can be removed from the esophagus 60 asdescribed above.

In a gastric narrowing use shown in FIG. 36, a tube 70 can extend fromthe distal end 10 b of the deployed anastomotic device 10 of FIG. 35. Insuch a case, the pyloric section of the stomach 62 can be heldpermanently open by the insertion of the device 10, thereby enhancingrapid transit of digested food and reducing absorption. The diameter andlength of the tube 70 can vary, but by way of non-limiting example canbe about 1 cm in diameter and about 4 cm in length. In anothernon-limiting example, the diameter can be about 1.6 cm. The volume ofthe tube 70 can also vary but in one embodiment is in the range of about10 to 30 m1s. The tube 70 can extend between the distal portion 12 b ofthe device 10 and the stomach 62, or it can extend in length on eitherend. For example, the tube 70 can pass through the pylorus or any othersmall bowel to inhibit local absorption of digested food. The inletdiameter of the device 10 can also be reduced as described above.

During gastro-esophageal deployment of the device 10 such as in agastric reflux use, illustrated in FIGS. 37-39, it may be desirable tofix a band 72 around the esophagus 60 to compress tissue against thenon-expanded section (proximal portion 12 a) of the outer elongate body12. The band 72 can include any surgically safe device capable ofsecuring tissue, e.g., a section of suture or a flexible member. Theband 72 is typically fixed following deployment of the distal wings 16 band prior to deployment of the proximal wings 16 a, but the sequence ofevents can vary. To fix the band 72, the endoscope 64 can be advancedthrough a hole 74 in the stomach wall and onward until its end 66provides a view of an esophageal wall 76, e.g., by being adjacent to thewall 76. Tools can be advanced through the working channel of theendoscope 64 to position the band 72 around the esophagus 60. The band72 can be tightened around the esophagus 60 to compress the esophagealwall 76 against the outer elongate body 12 positioned within theesophageal lumen as shown in FIG. 38. The endoscope 64 can be withdrawninto the stomach 62, the proximal wings 16 a can be deployed, and theactuator 20 can be removed as shown in FIG. 39. Although the proximaland distal portions 12 a, 12 b are typically in fluid communication, insome embodiments such as in the gastric reflux use, a closure element,such as a solid pin made of surgically safe material, can be disposed inthe mid-portion area 13 between the proximal and distal wings 16 a, 16 bto prevent fluid leakage. The hole 74 in the stomach wall 68 can berepaired using any technique, such as using another embodiment of ananastomotic device 80 illustrated in FIGS. 40-42.

The anastomotic device 80 of FIG. 40 is similar in form and function tothe device 10 of FIG. 1 except that a mid-portion 84 of a generallyelongate tubular body 82 of the device 80 is reduced in size compared toits proximal and distal portions 82 a, 82 b. The mid-portion 84 can haveany cross-sectional shape, e.g., elliptical (including circular). Theproximal and distal portions 82 a, 82 b can have the same or differentcross-sectional shapes as the mid-portion 84, although the proximal anddistal portions 82 a, 82 b typically have the same cross-sectional shapeas each other. Once deployed, the mid-portion 84 can be positionedwithin the hole 74 as shown in FIG. 41, with deployed proximal anddistal wings 86 a, 86 b bearing against the stomach walls on each side.

In yet another use, the anastomotic device 10 can be placed acrossobstructions within the body to recreate a body lumen. One such exampleis across a prostate 88, as illustrated in FIGS. 42-43. The anastomoticdevice 10 can be advanced across the prostate 88, and the distal wings16 b can be deployed into tissue. The non-expandable mid-portion 13 canbe of sufficient length to cross an obstruction (e.g., the prostate 88)so that the proximal wings 16 a can be expanded on the opposite side andnot interfere with other parts of the body, e.g., an external sphincter90. The device 10 can also be deployed across the prostate 88 such thatthe distal wings 16 b are located within a bladder 92, as shown in FIG.43. Once deployed, the distal wings 16 b can be withdrawn against abladder neck 94. The proximal wings 16 a can then be deployed on theother side of the obstruction 88, thereby providing an open conduitbetween both ends. The deployed distal and proximal wings 16 a, 16 bgenerally inhibit migration of the device 10.

FIG. 44 illustrates another embodiment of an anastomotic device 50,which in an exemplary embodiment is configured for use in endovascularaneurysm repair (EVAR), such as in treating infra-renal aneurysms. Theanastomotic device 50 is similar in form and function to the device 10of FIG. 1 except that, while a proximal end 51 of the device 50 includestabs 52 (similar to the tabs 15 a, 15 b described above), a distal end53 of the device 50 does not include tabs. At least the distal end 53 isformed from a deformable material to allow the distal end 53 to bedeformed into a desired configuration. The distal end 53, and optionallythe entire device, can also or alternatively be formed from a shapememory material.

In one exemplary EVAR procedure, illustrated in FIGS. 45-46, locationsof side branch protrusions 55 a, 55 b of an artery 57 and any otherrelated information (e.g., orientation, length, and diameter of theprotrusions 55 a, 55 b and/or the arterial aneurysm) can be determined.Devices such as guidewires, radiopaque rings, or stents can be insertedinto the side branch protrusions 55 a, 55 b to mark their locations. Ananeurysm graft 59 can be inserted and deployed in the artery 57. Aninstrument such as a curved needle inserted through the graft 59 can beused to puncture through the graft 59 at junctions 63 a, 63 b betweenthe artery 57 and the side branch protrusions 55 a, 55 b, and aguidewire can be inserted into each of the side branch protrusions 55 a,55 b through the needles, and the needles can be removed. If necessary,one or more devices (e.g., a series of dilators increasing in diameter,a dilator having a screw head at its distal end, a hole punch, aninflatable balloon with blades attached to its surface, wings havingcutting edges, etc.) can be advanced over each guidewire to facilitatefurther expanding of the puncture in the graft 59 at either or bothjunctions 63 a, 63 b between the artery 57 and the side branchprotrusions 55 a, 55 b. A person skilled in the art can appreciate thatthe guidewires can be inserted into either of the side branchprotrusions 55 a, 55 b at any time during the procedure, although theyare typically deployed before any devices 50.

A first anastomotic device 50 can be advanced over one of the guidewiresextending into one of the side branch protrusions 55 a, 55 b with thedevice's distal end 53 leading and extending into one of the side branchprotrusions 55 a, 55 b. As shown in FIG. 46, proximal wings 61 of thedevice 50 can be deployed inside the lumen of the graft 59, and theproximal wings 61 can be pushed against the wall of the graft 59 at thejunctions 63 a, 63 b. Distal wings 65 can be deployed on the other sideof the junction 63 a, 63 b, thereby anchoring the side branch protrusion55 a, 55 b to the graft 57 and sealing the junction 63 a, 63 b.Following deployment of the wings 61, 65, the distal end 53 can beflared outward to anchor its location within the side branch protrusion55 a, 55 b. For example, a balloon catheter can be used to cause thedistal end 53 to flare outward. Since the distal end 53 is formed froman deformable material, it will retain its flared shape. If a shapememory material such as nitinol is used to form the device 50, any ofthe wings 61, 65 and/or the distal end 53 can be heat set into position.

A person skilled in the art will appreciate that the various methods anddevices disclosed herein can be formed from a variety of materials.Moreover, particular components can be implantable and in suchembodiments the components can be formed from various biocompatiblematerials known in the art. Exemplary biocompatible materials include,by way of non-limiting example, composite plastic materials,biocompatible metals and alloys such as stainless steel, magnesiumalloys, titanium, titanium alloys and cobalt-chromium alloys, and anyother material that is biologically compatible and non-toxic to thehuman body.

One skilled in the art will appreciate further features and advantagesbased on the above-described embodiments. Accordingly, the descriptionis not to be limited by what has been particularly shown and described,except as indicated by the appended claims.

What is claimed is:
 1. A method for forming an anastomosis between twobody lumens, comprising: positioning an outer elongate tubular body,disposed around an inner elongate tubular body, within at least one bodylumen, the inner elongate tubular body having slots formed at proximaland distal portions of the inner elongate tubular body; rotatingproximal and distal portions of the outer elongate tubular body to causethe proximal and distal portions of the outer elongate tubular body toexpand to form proximal and distal wings that extend toward one anotherto engage tissue of the at least one body lumen between the proximal anddistal wings and thereby form a fluid flow pathway through the at leastone body lumen; and adjusting a distance between the proximal and distalwings by engaging protrusions formed on an inner sidewall of theproximal and distal portions of the outer elongate tubular body with atleast some of the slots.
 2. The method of claim 1, wherein the proximaland distal wings include tissue engaging mechanisms that grasp thetissue as the wings are formed.
 3. The method of claim 1, furthercomprising anchoring the at least one body lumen to the outer elongatetubular body prior to rotating the proximal and distal portions of theouter elongate tubular body.
 4. The method of claim 1, wherein theproximal and distal portions of the outer elongate tubular body arerotated using an actuator.
 5. The method of claim 1, wherein theproximal and distal portions of the outer elongate tubular body arecompressed as they are rotated to form proximal and distal wings.
 6. Themethod of claim 1, wherein positioning the outer elongate body includesextending the outer elongate body between two openings in first andsecond body lumens to be joined.
 7. The method of claim 1, wherein theat least one body lumen is a blood lumen.
 8. The method of claim 1,wherein rotating the proximal and distal portions of the outer elongatetubular body comprises rotating the outer elongate tubular body in afirst direction to cause only one of the proximal and distal portions ofthe outer elongate tubular body to expand to form one of the proximaland distal wings, and subsequently rotating the outer elongate tubularbody in a second direction to cause another one of the proximal anddistal portions of the outer elongate tubular body to expand to formanother one of the proximal and distal wings.
 9. The method of claim 1,wherein the inner elongate tubular body is attached to the outerelongate tubular body.
 10. The method of claim 1, wherein the proximaland distal wings are formed concurrently.
 11. The method of claim 1,wherein the proximal and distal wings are formed sequentially.